Ensemble Programme an Early Intervention for Informal Caregivers of Psychiatric Patients

NCT04020497 | Completed Results DMC

• 1 other identifier: EnsembleRCT
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This study focuses on the difficulties of maintaining optimal psychological health and quality of life for caregivers in adult psychiatry while they play an important role in helping patients with severe psychiatric disorders. It evaluates the addition of a 5 session psychological program, named Ensemble. Half of the participants will receive their usual support and Ensemble in combination, while the other half will receive usual support only.

Conditions

Psychological Distress

Keywords

target support; informal caregiver; recovery; well-being; burden; quality of life

Outcome Measures

Primary Outcomes (1)

• General Distress by Global Severity Index

  The Brief Symptom Inventory (BSI) invlude normative data to detect clinical symptoms as indicators of emotional distress, with 53 items on a 5-point Likert-type scale (0-4), ranging from "not at all"=0 to "extremely=4." The items measure physical and psychological symptoms occurring in the preceding 7-day period. It includes three global indices: Global Severity Index (GSI, indicating the global distress level), Positive Symptom Total (PST, indicating the number of symptoms an individual reports) and Positive Symptom Distress Index (PSDI, indicating the average distress level).The Global Severity Index (GSI) is a composite score to measure global distress Min = 0; Max=212: Range 0-3.83, a higher score reprensent a severer global distress level. The interpretation

  Baseline, T1 at 2 months, and T2 at 4 months

Secondary Outcomes (4)

• Optimism Level

  Baseline, T1 at 2 months, and T2 at 4 months

• Quality of Live - Mental Dimension

  Baseline, T1 at 2 months, and T2 at 4 months

• Burden Level

  Baseline, T1 at 2 months, and T2 at 4 months

• Patient's Social an Occupational Functioning

  Baseline and T2 at 4 months

Study Arms (2)

Ensemble + SAU (Support as usual)

EXPERIMENTAL

The five-session Ensemble program provided to informal caregivers targeted support + SAU

Behavioral: Ensemble programme; Other: SAU

SAU (Support as usual)

ACTIVE COMPARATOR

SAU alone which was chosen as a control condition.

Other: SAU

Interventions

Ensemble programme BEHAVIORAL

Ensemble is a individualized programme to address informal caregiver's specific unmet needs, emotions and social resources, in order to offer a targeted support in five sessions.

Also known as: Ensemble

Ensemble + SAU (Support as usual)

SAU OTHER

Informal caregivers have often to manage the situation in usual different ways. Support as usual (SAU) alone consists of an informal support by patient's clinical team. Specific psychoeducational programs depending on patient's illnes (like "Profamille" for schizophrenia) or peer-support depending to the voluntary work of families' associations. Some general professional services focused on informal caregivers or relatives in order to inform and orient them if they are avaible in the study area. No attempts have been made to standardize this treatement as SAU depend to informal caregiver's need and knowledge of the health system, also her/his capacity or possibility to be in contact with patient's clinical team.

Also known as: Support as usual

Ensemble + SAU (Support as usual); SAU (Support as usual)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being at least 18 years old
• Living in the French-speaking cantons of Switzerland (commonly referred to as "Romandy")
• Speaking French
• Having an adult relative suffering from a psychiatric disorder (with or without an established diagnosis)
• Having the capacity to agree to participate in the project

You may not qualify if:

• \- Having les than 20 on the Zarit score.

Sponsors & Collaborators

• Institut et Haute Ecole de la Santé la Source: lead

Study Sites (1)

La Source, School of Nursing Sciences, HES-SO University of Applied Sciences Western Switzerland, Lausanne.

Lausanne, Canton of Vaud, 1004, Switzerland

Location

Related Publications (3)

• Rexhaj S, Monteiro S, Golay P, Coloni-Terrapon C, Wenger D, Favrod J. Ensemble programme for early intervention in informal caregivers of psychiatric adult patients: a protocol for a randomised controlled trial. BMJ Open. 2020 Jul 30;10(7):e038781. doi: 10.1136/bmjopen-2020-038781.

  PMID: 32737097 BACKGROUND

• Rexhaj S, Nguyen A, Favrod J, Coloni-Terrapon C, Buisson L, Drainville AL, Martinez D. Women involvement in the informal caregiving field: A perspective review. Front Psychiatry. 2023 Jan 18;14:1113587. doi: 10.3389/fpsyt.2023.1113587. eCollection 2023.

  PMID: 36741114 BACKGROUND

• Rexhaj S, Martinez D, Golay P, Coloni-Terrapon C, Monteiro S, Buisson L, Drainville AL, Bonsack C, Ismailaj A, Nguyen A, Favrod J. A randomized controlled trial of a targeted support program for informal caregivers in adult psychiatry. Front Psychiatry. 2023 Nov 30;14:1284096. doi: 10.3389/fpsyt.2023.1284096. eCollection 2023.

  PMID: 38098635 RESULT

MeSH Terms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr Shyhrete Rexhaj
• Organization: Institut et Haute Ecole de la Santé la Source

s.rexhaj@ecolelasource.ch

0791031816

Study Officials

• Shyhrete Rexhaj

  Institut et Haute école de la Santé, La Source

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Porfessor associate HES

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 16, 2019
• Study Start: September 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: April 30, 2023
• Last Updated: September 25, 2026
• Results First Posted: September 25, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)